MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP MONITOR; ICP MONITOR-CERELINK

Model Number 826820

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

1 of 2 reports.Other mfg report number: 3013886523-2022-00270.A facility reported that after successful zeroing and implantation, the monitor started showing negative value (-50).The value slowly recovered to 0 and the cerelink monitor indicated that either the sensor or the cable had to be replaced.After replacing the cable everything seemed to be working as expected.No patient injury.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h7, h10 the cerelink monitor was not returned for evaluation as the device is still in use by the facility; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: CERELINK ICP MONITOR
• Type of Device: ICP MONITOR-CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14712116
• MDR Text Key: 294526721
• Report Number: 3014334038-2022-00125
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780533788
• UDI-Public: 10381780533788
• Combination Product (y/n): N
• PMA/PMN Number: K183406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 826820
• Device Catalogue Number: 826820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2022
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1